21 C.F.R. § 520.1044a Gentamicin sulfate oral solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin. (b) Sponsor. See Nos. 000061 and 054925 in §510.600(c) of this chapter. (c) Related tolerances. See §556.300 of this chapter. (d) Conditions of use—(1) Amount. Colibacillosis: 1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligram/pound/day. (2) Indications for use. In weanling swine for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with Treponema hyodysenteriae. (3) Limitations. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Treatment may be repeated if dysentery recurs. Do not slaughter treated swine for food for at least 3 days following treatment. [48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1044a Gentamicin sulfate oral solution.
